Four Organisms Added to Domestic List

Summary#

Order 2023-112-06-01 Amending the Domestic Substances List adds four living organisms to the Domestic Substances List. The change removes these organisms from the requirement to go through the New Substances notification process for organisms. The order came into force on its registration date, May 11, 2023.

What it does#

• Adds four living organisms to the Domestic Substances List (Parts 5 and 7):
  • Human T lymphocytes transduced with a lentiviral vector pseudotyped with the vesicular stomatitis virus glycoprotein envelope, encoding the chimeric antigen receptor (CAR) targeting the human B cell CD19 antigen expressed under the control of the human elongation factor 1 α (EF-1α) promoter
  • Recombinant non-replicating adeno-associated virus serotype 6 vector encoding B-domain deleted human coagulation Factor VIII (PF-07055480)
  • Recombinant replication-deficient adeno-associated viral vector serotype 2 expressing the human retinal pigment epithelium protein (rAAV2-hRPE65v2-LTW888)
  • Saccharomyces species, S1077-H06 — listed under its masked identifier 19658-6
• As a result, these organisms are no longer subject to the New Substances Notification Regulations (Organisms) for new-substance notification.
• The ministers (Environment and Health) reviewed the information and determined the criteria for adding these organisms were met, and no special conditions were in effect for them.

Who's affected#

• Companies, research labs, or other organizations that manufacture, import or use these specific living organisms in Canada.
• In practice, this is most relevant to biotechnology and biomedical firms and researchers working with the listed viral vectors and engineered immune cells.
• The change is administrative: it removes a specific notification step. It does not create new approvals or safety exemptions.

Why it matters#

• Making these organisms part of the Domestic Substances List removes a regulatory notification hurdle. That can make it easier and quicker for businesses and researchers to obtain, move, or use these specific organisms in Canada.
• This is an administrative, not a safety, decision: the order does not mean the government endorses the organisms, nor does it exempt them from other laws or safety rules that may still apply.
• The action follows the Canadian Environmental Protection Act, 1999 and is a routine step once the required assessments and timelines are complete.